Principal Biostatistician; Associate Director Level

Early Development Principal Statistician

This role is in Early Development Biometrics (EDB), a core function within Product Development Data Sciences (PDD) that provides strategic leadership and scientific rigor across early clinical development  partner across Biostatistics, Analytical Data Science, and Data Management to enable data-driven decision-making from first-in-human through proof-of-concept studies.

As trusted partners in early development, we design efficient and innovative clinical trials, apply rigorous statistical methods, and implement high-quality programming and analytical solutions to accelerate timelines, de-risk development, and increase the probability of technical success. Our integrated teams operate with agility and scientific depth, supporting exploratory analyses, early regulatory engagements, and complex data-generation needs across therapeutic areas. Together, we bring scientific rigor, technical innovation, and strategic insight to shape the future of early development and deliver better outcomes for patients.

Early Development Biometrics is also home to the Statistical Methodology group, which enables the most impactful use of quantitative methodology across PDD through internal consultation, external collaboration, and continuous capability building; and Visual Analytics, which creates and maintains interactive dashboards that drive high-quality Medical Data Review (MDR) and safety signal detection, aligned with Risk-Based Quality Management (RBQM) principles and Critical-to-Quality (CtQ) endpoints.

The Opportunity:

The Early Development Principal Statistician is a critical partner in the design and analysis of exploratory clinical studies, applying statistical expertise to guide early-phase trial strategy, design, and interpretation. This role ensures scientific rigor while maintaining the flexibility needed for hypothesis generation and signal detection. Responsibilities include contributing to protocol design, developing statistical analysis plans, and analyzing complex, often high-dimensional data to inform early go/no-go decisions and regulatory interactions.

The Statistician helps shape the early clinical narrative by ensuring data are robust, interpretable, and aligned with the evolving development strategy.

You lead the statistical design of complex or high priority early phase studies, including adaptive, platform, and biomarker enriched trials

You champion the use of innovative methodologies, for example Bayesian designs and model based dose selection, aligned with exploratory objectives and scientific hypotheses

You ensure strategic alignment and quality across statistical deliverables within early phase programs, shaping the statistical framework that supports phase transitions, internal governance reviews, and regulatory interactions

You solve complex statistical challenges in early development using deep expertise and novel approaches, such as integrating translational data, navigating sparse or emerging datasets, and balancing speed with scientific rigor

You interpret and drive the narrative around emerging data, translating early signals into clear, meaningful insights for internal stakeholders and external communications

You own the statistical content of major early regulatory submissions, such as INDs, EMA scientific advice packages, and pre IND or end of Phase 1 meetings, ensuring clarity, integrity, and scientific robustness

You lead sub streams and functional contributions within disease area strategy and the integration of novel data sources, for example omics, imaging, and real world data

You maintain strong connectivity and collaboration with other core biometrics functions within PDD, including Biostatistics, Analytical Data Science, and Data Management, ensuring early phase analysis strategies are executable

Who You Are:

You hold a PhD or MSc in Statistics, Biostatistics, or a closely related quantitative field

You bring at least 6 years of experience in clinical trial statistics, including responsibility for study level strategy and decision making

You have a proven ability to lead statistical input into clinical development plans and regulatory submissions

You have strong expertise applying advanced statistical methods to enable data driven decision making

You are proficient in SAS and or R and deeply familiar with CDISC standards and evolving regulatory data requirements

You demonstrate independent thinking and make decisions based on sound principles

Preferred:

Extensive experience working in cross-functional, global early development teams, with demonstrated ability to collaborate effectively across Clinical Development, Clinical Pharmacology, Translational Medicine, Regulatory, and Biomarker teams.

Effective communication skills, including the ability to translate complex or exploratory statistical methodologies into actionable insights for clinical, regulatory, and non-technical audiences.

Experience across multiple phases of drug development, with a strong…